EP2395994A1 - Compositions moussantes de peroxyde de benzoyle pour administration topique - Google Patents

Compositions moussantes de peroxyde de benzoyle pour administration topique

Info

Publication number
EP2395994A1
EP2395994A1 EP09840157A EP09840157A EP2395994A1 EP 2395994 A1 EP2395994 A1 EP 2395994A1 EP 09840157 A EP09840157 A EP 09840157A EP 09840157 A EP09840157 A EP 09840157A EP 2395994 A1 EP2395994 A1 EP 2395994A1
Authority
EP
European Patent Office
Prior art keywords
concentrate
weight
composition
mixture
propellant
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP09840157A
Other languages
German (de)
English (en)
Other versions
EP2395994A4 (fr
Inventor
Ronald M. Gurge
Mark W. Trumbore
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Precision Dermatology Inc
Original Assignee
Precision Dermatology Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Precision Dermatology Inc filed Critical Precision Dermatology Inc
Publication of EP2395994A1 publication Critical patent/EP2395994A1/fr
Publication of EP2395994A4 publication Critical patent/EP2395994A4/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/124—Aerosols; Foams characterised by the propellant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/327—Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/10—Anti-acne agents

Definitions

  • Acne is a pleomorphic skin disease characterized by blackheads, whiteheads, papules, pustules, and cysts.
  • the lesions are often contaminated with bacteria, which can lead to secondary infections.
  • the appearance of acne ranges from slight skin irritation to pitting. In extreme cases, acne leads to the development of disfiguring scars.
  • Therapeutic approaches to treating acne include prevention of obstruction of the follicular duct, reopening the duct if it has become blocked, combating any infecting bacteria, or reducing the thickened sebum, and combinations of these approaches.
  • the horny outer layer of the skin (stratum corneum) is formed of dead cells composed largely of keratin.
  • Therapeutic agents which act to prevent the obstruction of the follicular duct by the removal of excess keratin are known as keratolytic agents.
  • Salicylic acid, sulfur, and resorcinol have been employed as keratolytic agents in the management of acne for at least 100 years.
  • benzoyl peroxide an organic peroxide
  • BPO benzoyl peroxide
  • Benzoyl peroxide [(CeHsCO) 2 O 2 ] is a colorless, odorless, tasteless, crystalline solid, which is a powerful oxidizing agent, yet nontoxic to man.
  • BPO products While benzoyl peroxide is recognized by the F. D. A. as effective in concentrations between 2.5% and 10% for the local treatment of skin lesions, such as those developed in acne or seborrhea, it has the adverse side effect of causing contact irritation and dryness. Additionally, a small percentage of the population experiences a mild allergic reaction to certain benzoyl peroxide formulations. Furthermore, BPO products have a characteristic odor and can stain clothing. These negative aesthetic product attributes can have an effect on patient compliance. Accordingly, some patients are unable to derive the benefits provided by BPO acne therapy.
  • BPO is extremely unstable. Under most conditions, BPO decomposes in both solid and solution state; the rate of degradation increases exponentially with an increase in temperature. Due to its strong oxidative capabilities, BPO reacts unpredictably with other compounds and it is very difficult to obtain stabilized formulations. Therefore, common shortcomings of products containing BPO (alone or in combination with additional active ingredients) are falloff of activity and efficacy with time, and their associated short shelf lives.
  • a 10% benzoyl peroxide foam is available. This product utilizes propane and butane as propellants, both of which are extremely flammable.
  • the product therefore, combines two incompatible hazardous classes of compounds in an aerosol container: an oxidizer (benzoyl peroxide); and flammable hydrocarbons (butane and propane). This creates a safety issue and a potential explosion hazard within the product container.
  • oxidizer benzoyl peroxide
  • flammable hydrocarbons butane and propane
  • compositions comprising benzoyl peroxide, which exhibit enhanced stability, even under accelerated conditions.
  • the compositions also exhibit reduced color formation and enhanced moisturizing properties, as compared to known formulations of benzoyl peroxide.
  • the compositions can be formulated into a topical aerosol foam and used in cosmetics or pharmaceuticals.
  • the compositions are useful in the treatment of acne and other skin conditions. Additionally, methods of formulating these compositions are described.
  • Figure 1 depicts formulation E (from Table 1; BPO (1 g) + water (9 g) + HFA 134a
  • Figure 2 depicts formulation G (from Table 1; BPO (1 g) + water (9 g) + HFA 134a (12 g) + argon purge, 2 min) after storage under accelerated conditions (6 months @ 30 0 C).
  • "*" indicates a statistically significant difference (p ⁇ 0.05) at the 95% confidence interval.
  • the invention relates to aqueous compositions of BPO which exhibit enhanced chemical and physical stability and reduced color formation.
  • the compositions feature a semi-solid oil phase.
  • the compositions do not contain volatile lower alcohols.
  • the compositions comprise an aerosol propellant.
  • the aerosol propellant is a hydrofluoroalkane propellant (HFA).
  • the compositions produce a foam upon actuation of an aerosol container charged with the composition.
  • the foams are stable against collapse.
  • the foams rub-in quickly without a greasy residue.
  • the foam is moisturizing.
  • the foam is non-irritating.
  • Propellants There are several possible choices of propellants for a BPO aerosol foam, including, but not limited to, CFCs, hydrocarbons, compressed gases, and HFAs.
  • CFCs chlorofluorocarbons
  • HFAs hydrogen fluoride
  • hydrocarbon propellants demonstrate very low reactivity and good resistance to free-radical attack.
  • hydrocarbon propellants are highly flammable and it would be undesirable and hazardous to combine these propellants with benzoyl peroxide, a strong oxidizer, in an aerosol foam system.
  • the chemical classes of "oxidizer” and "flammable” are known to be incompatible.
  • compressed inert gases such as nitrogen and carbon dioxide
  • compressed inert gases can be used as an aerosol propellant. While offering good chemical stability due to their non-reactivity, they are unable to deliver consistent product delivery throughout the life of the aerosol can due to their high vapor pressures.
  • HFAs hydrofluoroalkanes, also known as hydrofluorocarbons, or HFCs.
  • HFAs hydrofluoroalkanes, also known as hydrofluorocarbons, or HFCs
  • HFA propellants are pharmaceutically acceptable, generally non-reactive, and ozone-friendly. However, in the presence of free-radicals, HFA propellants are susceptible to free-radical attack. Labile hydrogen atoms can be abstracted due to the electron- withdrawing effects of the fluorine atoms, resulting in a hydro fluorocarbon radical.
  • HFAs have been shown to form a hydro-fluorocarbon radical in the presence of hydroxyl radical (•OH).
  • hydroxyl radical •OH
  • Post-initiation, the resulting reactive, hydrofluorocarbon radical has the potential to promote a variety of cascading, free-radical decompositions of other compounds in its presence.
  • the invention relates to the formation of a stable benzoyl peroxide aerosol foam formulation, thus overcoming the expected and well-known stability issues associated with the fluorinated propellant system.
  • compositions are formulated such that the chemical instability due to the nature of the propellant is reduced.
  • compositions were formulated with the addition of antioxidants to the concentrate. Additionally, the air in the container headspace was replaced with an inert gas (argon).
  • argon inert gas
  • Compositions formulated in this way exhibited improved BPO stability in the presence of HFA propellants (HFA 134a and HFA 227).
  • HFA 134a and HFA 227) HFA propellants
  • addition of argon and antioxidants to the system results in only a 23.2% average loss of BPO when stored for three months at accelerated conditions (40 °C/75% relative humidity). See Tables 1 and 2.
  • the ratio of BPO/antioxidant utilized was 100 : 1 (5 % BPO formulations) or 200 : 1 ( 10% BPO formulations), a ratio 20- to 40-times lower than the ratio previously reported to be required.
  • Topical formulations of benzoyl peroxide are known to be generally irritating and lack the ability to hydrate skin. These two negative attributes can lead to reduced patient compliance with its concomitant impact of therapeutic response. It was surprisingly found that embodiments of the inventive aerosol foam formulations of benzoyl peroxide were no more irritating than vehicle control and demonstrated similar levels of erythema as intact untreated skin. Figure 3 shows the level of skin irritation as measured by redness value for untreated, vehicle-treated, and benzoyl peroxide foam-treated skin. It was also surprisingly discovered that, in contrast to marketed benzoyl peroxide products of similar potency, embodiments of the inventive aerosol foam formulations of benzoyl peroxide had the ability to moisturize skin.
  • Figure 4 shows the ability of an aerosol foam formulation of benzoyl peroxide to improve skin moisturization. This figure also shows the lack of moisturization activity in marketed products.
  • DEFINITIONS For convenience, certain terms employed in the specification and appended claims are collected here. These definitions should be read in light of the entire disclosure and understood as by a person of skill in the art.
  • a reference to "A and/or B", when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
  • a reference to "A or B" when used in conjunction with open-ended language such as “comprising” can refer, in one embodiment, to A only (optionally including elements other than B); in another embodiment, to B only (optionally including elements other than A); in yet another embodiment, to both A and B (optionally including other elements); etc.
  • the phrase "at least one,” in reference to a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed within the list of elements and not excluding any combinations of elements in the list of elements.
  • At least one of A and B can refer, in one embodiment, to at least one, optionally including more than one, A, with no B present (and optionally including elements other than B); in another embodiment, to at least one, optionally including more than one, B, with no A present (and optionally including elements other than A); in yet another embodiment, to at least one, optionally including more than one, A, and at least one, optionally including more than one, B (and optionally including other elements); etc.
  • the order of the steps or acts of the method is not necessarily limited to the order in which the steps
  • the propellant is a HFA or a mixture of one or more hydro fluorocarbons.
  • Suitable hydro fluorocarbons include 1,1,1,2-tetrafluoroethane (HFA)
  • HFA 227 1,1, 1,2,3, 3,3-heptafluoropropane
  • CFC chlorofluorocarbon
  • Benzoyl peroxide works as a peeling agent, increasing skin turnover and clearing pores. Additionally, it is an antibacterial. This combination of uses makes it an ideal treatment for acne and other types of skin ulcers.
  • One or more additional active agents may be present in the composition. These include any material that has a desired effect when applied topically to a mammal, particularly a human. Suitable classes of active agents include, but are not limited to, antibiotic agents, antimicrobial agents, anti-acne agents, antibacterial agents, antifungal agents, antiviral agents, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, anesthetic agents, antipruriginous agents, antiprotozoal agents, anti-oxidants, antihistamines, vitamins, and hormones. 3.1 Antibiotics
  • antibiotics include, without limitation, octopirox, erythromycin, zinc, tetracyclin, triclosan, azelaic acid and its derivatives, phenoxy ethanol and phenoxy proponol, ethyl acetate, clindamycin and meclocycline; sebostats such as flavinoids; alpha and beta hydroxy acids; and bile salts such as scymnol sulfate and its derivatives, deoxycholate and cholate.
  • the antibiotic can be an antifungal agent.
  • Suitable antifungal agents include, but are not limited to, clotrimazole, econazole, ketoconazole, itraconazole, miconazole, oxiconazole, sulconazole, butenafme, naftifme, terbinafme, undecylinic acid, tolnaftate, and nystatin.
  • non-steroidal anti-inflammatory agents include, without limitation, oxicams, such as piroxicam, isoxicam, tenoxicam, sudoxicam; salicylates, such as aspirin, disalcid, benorylate, trilisate, safapryn, solprin, diflunisal, and fendosal; acetic acid derivatives, such as diclofenac, fenclofenac, indomethacin, sulindac, tolmetin, isoxepac, furofenac, tiopinac, zidometacin, acematacin, fentiazac, zomepirac, clindanac, oxepinac, felbinac, and ketorolac, fenamates, such as mefenamic, meclofenamic, flufenamic, niflumic, and tolfenamic acids; propionic acid derivatives, such as iopir
  • steroidal anti-inflammatory drugs include, without limitation, corticosteroids such as hydrocortisone, hydroxyl-triamcinolone, alpha-methyl dexamethasone, dexamethasone -phosphate, beclomethasone dipropionates, clobetasol valerate, desonide, desoxymethasone, desoxycorticosterone acetate, dexamethasone, dichlorisone, diflorasone diacetate, diflucortolone valerate, fluadrenolone, fluclorolone acetonide, fludrocortisone, flumethasone pivalate, fluosinolone acetonide, fluocinonide, flucortine butylesters, fluocortolone, fluprednidene (fluprednylidene) acetate, flurandrenolone, halcinonide, hydrocortisone acetate, hydrocortisone butyrate
  • Suitable anesthetics include the aminoacylanilide compounds such as lidocaine, prilocaine, bupivacaine, levo-bupivacaine, ropivacaine, mepivacaine and related local anesthetic compounds having various substituents on the ring system or amine nitrogen; the aminoalkyl benzoate compounds, such as procaine, chloroprocaine, propoxycaine, hexylcaine, tetracaine, cyclomethycaine, benoxinate, butacaine, proparacaine, butamben, and related local anesthetic compounds; cocaine and related local anesthetic compounds; amino carbonate compounds such as diperodon and related local anesthetic compounds; N- phenylamidine compounds such as phenacaine and related anesthetic compounds; N- aminoalkyl amide compounds such as dibucaine and related local anesthetic compounds; aminoketone compounds such as falicaine, dyclonine and related
  • Suitable antimicrobial agents include, but are not limited to, antibacterial, antifungal, antiprotozoal and antiviral agents, such as beta-lactam drugs, quinolone drugs, ciprofloxacin, norfloxacin, tetracycline, erythromycin, amikacin, triclosan, doxycycline, capreomycin, chlorhexidine, chlortetracycline, oxytetracycline, clindamycin, ethambutol, metronidazole, pentamidine, gentamicin, kanamycin, lineomycin, methacycline, methenamine, minocycline, neomycin, netilmicin, streptomycin, tobramycin, and miconazole.
  • beta-lactam drugs such as beta-lactam drugs, quinolone drugs, ciprofloxacin, norfloxacin, tetracycline, erythromycin, amikacin, triclosan,
  • tetracycline hydrochloride famesol, erythromycin estolate, erythromycin stearate (salt), amikacin sulfate, doxycycline hydrochloride, chlorhexidine gluconate, chlorhexidine hydrochloride, chlortetracycline hydrochloride, oxytetracycline hydrochloride, clindamycin hydrochloride, ethambutol hydrochloride, metronidazole hydrochloride, pentamidine hydrochloride, gentamicin sulfate, kanamycin sulfate, lineomycin hydrochloride, methacycline hydrochloride, methenamine hippurate, methenamine mandelate, minocycline hydrochloride, neomycin sulfate, netilmicin sulfate, paromomycin sulfate, streptomycin sulfate, tobramycin sulfate, miconazo
  • Keratolytic agents include, but are not limited to, urea, salicylic acid, papain, sulfur, glycolic acid, pyruvic acid, resorcinol, N-acetylcysteine, retinoids such as retinoic acid and its derivatives (e.g., cis and trans, esters), alpha hydroxy acids, beta hydroxy acids, coal tar, and combinations thereof.
  • Suitable keratolytic agents include, but are not limited to, urea, salicylic acid, papain, sulfur, glycolic acid, pyruvic acid, resorcinol, N-acetylcysteine, retinoids such as retinoic acid and its derivatives (e.g., cis and trans, esters), alpha hydroxy acids, beta hydroxy acids, coal tar, and combinations thereof.
  • retinoids such as retinoic acid and its derivatives (e.g., cis and trans, esters)
  • alpha hydroxy acids beta
  • Suitable other agents include, but are not limited to, skin soothing agents, deodorant agents, antiperspirants, sun screening agents, sunless tanning agents, vitamins, hair conditioning agents, anti-irritants, anti-aging agents, and combinations thereof.
  • skin soothing agents include, but are not limited to, allantoin, aloe, avocado oil, green tea extract, hops extract, chamomile extract, colloidal oatmeal, calamine, cucumber extract, and combinations thereof.
  • vitamins examples include, but are not limited to, vitamins A, D, E, K, and combinations thereof.
  • sunscreens include, but are not limited to, p-aminobenzoic acid, Avobenzone, Cinoxate, Dioxybenzone, Homosalate, Menthyl anthranilate, Octocrylene,
  • Octyl methoxycinnamate Octyl salicylate, Oxybenzone, Padimate O
  • Phenylbenzimidazole sulfonic acid Sulisobenzone, Titanium dioxide, Trolamine salicylate, Zinc oxide, 4- methylbenzylidene camphor, Methylene Bis-Benzotriazolyl Tetramethylbutylphenol, Bis- Ethylhexyloxyphenol Methoxyphenyl Triazine, Terephthalylidene Dicamphor Sulfonic Acid, Drometrizole Trisiloxane, Disodium Phenyl Dibenzimidazole Tetrasulfonate,
  • composition may further include components adapted to improve the stability or effectiveness of the applied formulation.
  • Suitable preservatives for use in the present invention include, but are not limited to: ureas, such as imidazolidinyl urea and diazolidinyl urea; phenoxyethanol; sodium methyl paraben, methylparaben, ethylparaben, and propylparaben; potassium sorbate; sodium benzoate; sorbic acid; benzoic acid; formaldehyde; citric acid; sodium citrate; chlorine dioxide; quaternary ammonium compounds, such as benzalkonium chloride, benzethonium chloride, cetrimide, dequalinium chloride, and cetylpyridinium chloride; mercurial agents, such as phenylmercuric nitrate, phenylmercuric acetate, and thimerosal; and alcoholic agents, for example, chlorobutanol, dichlorobenzyl alcohol, phenylethyl alcohol, and benzyl alcohol.
  • ureas such
  • Suitable antioxidants include, but are not limited to, ascorbic acid and its esters, sodium bisulfite, butylated hydroxytoluene, butylated hydroxyanisole, tocopherols (such as ⁇ -tocopherol), sodium ascorbate/ascorbic acid, ascorbyl palmitate, propyl gallate, and chelating agents like EDTA (e.g., disodium EDTA), citric acid, and sodium citrate.
  • EDTA e.g., disodium EDTA
  • compositions of the present invention may also be used in the formulations of the present invention.
  • surfactants and Emulsif ⁇ ers Many topical formulations contain chemical emulsions which use surface active ingredients (emulsif ⁇ ers) to disperse dissimilar chemicals in a particular solvent system. For example, most lipid-like (oily or fatty) or lipophilic ingredients do not uniformly disperse in aqueous solvents unless they are first combined with emulsif ⁇ ers which form microscopic aqueous soluble micelles that contain a lipid-soluble interior and an aqueous- soluble exterior, resulting in an oil-in- water emulsion.
  • a molecule In order to be soluble in aqueous media, a molecule must be polar or charged so as to favorably interact with water molecules which are also polar.
  • an emulsif ⁇ er is typically used which forms stable micelles that contain the aqueous-soluble components in the micelle interior while the exterior of the micelle is lipophilic so that it can dissolve in the lipophilic solvent to form a water-in-oil emulsion. It is well known that such emulsions can be destabilized by the addition of salts or other charged ingredients which can interact with the polar or charged portions of the emulsif ⁇ er within an emulsion micelle. Emulsion destabilization results in the aqueous and lipophilic ingredients separating into two layers, potentially destroying the commercial value of a topical product.
  • Surfactants suitable for use in the present invention may be ionic or non-ionic. These include, but are not limited to: polysorbates (Polysorbate 20, Polysorbate 40, Polysorbate 60, Polysorbate 80), steareth-10, sodium dodecyl sulfate (sodium lauryl sulfate), lauryl dimethyl amine oxide, cetyltrimethylammonium bromide (CTAB), polyethoxylated alcohols, polyoxy ethylene sorbitan, octoxynol, N ,N- dimethyldodecylamine-N-oxide, hexadecyltrimethylammonium bromide (HTAB), polyoxyl 10 lauryl ether, bile salts (such as sodium deoxycholate or sodium cholate), polyoxyl castor oil, nonylphenol ethoxylate, cyclodextrins, lecithin, dimethicone copolyol, lauramide DEA, coc
  • emulsifiers for use in the formulations of the present invention include, but are not limited to, behentrimonium methosulfate-cetearyl alcohol, non-ionic emulsifiers like emulsifying wax, polyoxyethylene oleyl ether, PEG-40 stearate, cetostearyl alcohol, ceteareth-12, ceteareth-20, ceteareth-30, ceteareth alcohol, glyceryl stearate, PEG- 100 stearate, glyceryl stearate and PEG-100 stearate, steareth-2 and steareth-20, or combinations/mixtures thereof, as well as cationic emulsifiers like stearamidopropyl dimethylamine and behentrimonium methosulfate, or combinations/mixtures thereof.
  • Suitable topical vehicles and vehicle components for use with the formulations of the invention are well known in the cosmetic and pharmaceutical arts, and include such vehicles (or vehicle components) as water; organic solvents such as alcohols (particularly lower alcohols readily capable of evaporating from the skin such as ethanol), glycols (such as propylene glycol, butylene glycol, and glycerol), aliphatic alcohols (such as lanolin); mixtures of water and organic solvents (such as water and alcohol), and mixtures of organic solvents such as alcohol and glycerol (optionally also with water); lipid-based materials such as fatty acids, acylglycerols (including oils, such as mineral oil, and fats of natural or synthetic origin), phosphoglycerides, sphingolipids and waxes; protein-based materials such as collagen and gelatin; silicone-based materials (both non-volatile and volatile) such as cyclomethicone, demethiconol and dimethicone copolyol; hydrocarbon
  • compositions of the present invention are oil-in- water emulsions.
  • Liquids suitable for use in formulating compositions of the present invention include water, and water-miscible solvents such as glycols (e.g., ethylene glycol, butylene glycol, isoprene glycol, propylene glycol), glycerol, liquid polyols, dimethyl sulfoxide, and isopropyl alcohol.
  • glycols e.g., ethylene glycol, butylene glycol, isoprene glycol, propylene glycol
  • glycerol glycerol
  • liquid polyols e.g., dimethyl sulfoxide, and isopropyl alcohol.
  • aqueous vehicles may be present.
  • formulations without methanol, ethanol, propanols, or butanols are desirable.
  • moisturizers for use in the formulations of the present invention include, but are not limited to, lactic acid and other hydroxy acids and their salts, glycerol, propylene glycol, butylene glycol, sodium PCA, sodium hyaluronate, Carbowax 200, Carbowax 400, and Carbowax 800.
  • Suitable emollients for use in the formulations of the present invention include, but are not limited to, glycerol, PPG- 15 stearyl ether, lanolin alcohol, lanolin, lanolin derivatives, cholesterol, petrolatum, isostearyl neopentanoate, octyl stearate, mineral oil, isocetyl stearate, myristyl myristate, octyl dodecanol, dimethicone, phenyl trimethicone, cyclomethicone, C 12 -C 15 alkyl benzoates, dimethiconol, propylene glycol, and dicaprylate/dicaprate .
  • appropriate combinations and mixtures of any of these moisturizing agents and emollients may be used in accordance with the present invention.
  • Suitable viscosity adjusting agents for use in the formulations of the present invention include, but are not limited to, protective colloids or non-ionic gums such as hydroxyethylcellulose, xanthan gum, and sclerotium gum, as well as magnesium aluminum silicate, silica, microcrystalline wax, beeswax, paraffin, and cetyl palmitate.
  • protective colloids or non-ionic gums such as hydroxyethylcellulose, xanthan gum, and sclerotium gum
  • magnesium aluminum silicate, silica, microcrystalline wax, beeswax, paraffin, and cetyl palmitate may be utilized according to the present invention 9.
  • Additional constituents suitable for incorporation into the emulsions of the present invention include, but are not limited to: skin protectants, adsorbents, demulcents, emollients, moisturizers, buffering agents, sustained release materials, solubilizing agents, skin-penetration agents, abrasives, absorbents, anti-caking agents, anti-static agents, astringents (e.g., witch hazel, alcohol, and herbal extracts such as chamomile extract), binders/excipients, buffering agents, chelating agents, film forming agents, conditioning agents, opacifying agents, and pH adjusters (e.g., citric acid, sodium hydroxide, and sodium phosphate).
  • Suitable fragrances and colors may be used in the formulations of the present invention. Examples of fragrances and colors suitable for use in topical products are known in the art.
  • one constituent of a composition may accomplish several functions.
  • the present invention relates to constituents that may act as a lubricant, an emollient, or a skin-penetrating agent.
  • the multi-functional constituent is socetyl stearate, isopropyl isostearate, isopropyl palmitate, or isopropyl myristate. 10. Purging Gases
  • the air in the container charged with the composition is replaced by an inert gas.
  • the inert gas is selected from the group consisting of argon, nitrogen, and mixtures thereof.
  • the invention relates to a composition
  • a composition comprising a concentrate and a propellant, wherein the concentrate comprises an amount of benzoyl peroxide, wherein the amount of benzoyl peroxide is about 0.5% to about 15% by weight of the concentrate; an amount of water, wherein the amount of water is about 55% to about 95% by weight of the concentrate; and an amount of an antioxidant or a preservative, wherein the amount of the antioxidant or the preservative is about 0.01% to about 5% by weight of the concentrate; and the propellant is a hydrofluoroalkane propellant.
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate comprises an amount of benzoyl peroxide, wherein the amount of benzoyl peroxide is about 0.5% to about 15% by weight of the concentrate; an amount of water, wherein the amount of water is about 55% to about 95% by weight of the concentrate; and an amount of an antioxidant or a preservative, wherein the amount of the antioxidant or the preservative is about 0.05% to about 5% by weight of the concentrate; and the propellant is a hydrofluoroalkane propellant.
  • the concentrate comprises an amount of benzoyl peroxide, wherein the amount of benzoyl peroxide is about 0.5% to about 15% by weight of the concentrate; an amount of water, wherein the amount of water is about 55% to about 95% by weight of the concentrate; and an amount of an antioxidant or a preservative, wherein the amount of the antioxidant or the preservative is about 0.05% to about 5% by weight of the concentrate; and the propel
  • the invention relates to a composition consisting of a concentrate and a propellant, wherein the concentrate comprises an amount of benzoyl peroxide, wherein the amount of benzoyl peroxide is about 0.5% to about 15% by weight of the concentrate; an amount of water, wherein the amount of water is about 55% to about 95% by weight of the concentrate; and an amount of an antioxidant or a preservative, wherein the amount of the antioxidant or the preservative is about 0.1% to about 5% by weight of the concentrate; and the propellant is a hydrofluoroalkane propellant.
  • the concentrate comprises an amount of benzoyl peroxide, wherein the amount of benzoyl peroxide is about 0.5% to about 15% by weight of the concentrate; an amount of water, wherein the amount of water is about 55% to about 95% by weight of the concentrate; and an amount of an antioxidant or a preservative, wherein the amount of the antioxidant or the preservative is about 0.1% to about 5% by weight of the concentrate; and the propellant is a
  • the invention relates to the above-mentioned composition, wherein the hydrofluoroalkane propellant is 1,1,1,2-tetrafluoroethane, 1,1,1,2,3,3,3- heptafluoropropane, or a mixture thereof. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the hydrofluoroalkane propellant is 1,1,1,2-tetrafluoroethane. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in an amount from about 1.0% to about 13% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in an amount from about 2.5% to about 12% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in an amount from about 4.0% to about 7.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 5.0%, about 6.0%, about 7.0%, about 8.0%, about 9.0%, about 10.0%, about 11%, or about 12% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in about 5.3% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein water is present in an amount from about 60% to about 90% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein water is present in an amount from about 65% to about 90% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein water is present in an amount from about 72% to about 82% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein water is present in about 65%, about 70%, about 75%, about 80%, about 85%, or about 90% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein water is present in about 77% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is selected from the group consisting of imidazolidinyl urea, diazolidinyl urea, phenoxyethanol, sodium methyl paraben, methylparaben, ethylparaben, propylparaben, potassium sorbate, sodium benzoate, sorbic acid, benzoic acid, formaldehyde, citric acid, sodium citrate, chlorine dioxide, benzalkonium chloride, benzethonium chloride, cetrimide, dequalinium chloride, cetylpyridinium chloride, phenylmercuric nitrate, phenylmercuric acetate, thimerosal, chlorobutanol, dichlorobenzyl alcohol, phenyleth
  • the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is methylparaben, propylparaben, butylated hydroxytoluene, disodium EDTA, citric acid, sodium citrate, or a mixture thereof.
  • the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is present in an amount from about 0.05% to about 3.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is present in an amount from about 0.1% to about 2.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is present in an amount from about 0.5% to about 1.9% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is present in about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.5%, or about 2.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the antioxidant or the preservative is present in about 1.2% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the concentrate further comprises an emollient or a moisturizer.
  • the invention relates to the above-mentioned composition, wherein the emollient or the moisturizer is selected from the group consisting of glycerol, PPG- 15 stearyl ether, lanolin alcohol, lanolin, cholesterol, petrolatum, isostearyl neopentanoate, octyl stearate, mineral oil, isocetyl stearate, myristyl myristate, octyl dodecanol, dimethicone, phenyl trimethicone, cyclomethicone, Ci 2 -Ci 5 alkyl benzoates, dimethiconol, propylene glycol, lactic acid, butylene glycol, sodium PCA, carbowax 200, carbowax 400, carbowax 800, and mixtures
  • the invention relates to the above-mentioned composition, wherein the emollient or the moisturizer is glycerol, dimethicone, C12-C15 alkyl benzoates, propylene glycol, or a mixture thereof.
  • the invention relates to any one of the above-mentioned compositions, wherein the emollient or the moisturizer is present in an amount from about 5% to about 20% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emollient or the moisturizer is present in an amount from about 8% to about 17% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emollient or the moisturizer is present in an amount from about 9% to about 15% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the emollient or the moisturizer is present in an amount from about 9% to about 13% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emollient or the moisturizer is present in about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emollient or the moisturizer is present in about 11% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the concentrate further comprises an emulsifier or a surfactant.
  • the invention relates to the above-mentioned composition, wherein the emulsifier or the surfactant is selected from the group consisting of polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, steareth-10, sodium dodecyl sulfate, lauryl dimethyl amine oxide, cetyltrimethylammonium bromide (CTAB), polyoxyethylene sorbitan, octoxynol, N,N-dimethyldodecylamine-N-oxide, hexadecyltrimethylammonium bromide (HTAB), polyoxyl 10 lauryl ether, sodium deoxycholate, sodium cholate, polyoxyl castor oil, nonylphenol ethoxylate, cyclodextrins, lecithin, dimethicone
  • CTAB cet
  • the invention relates to the above-mentioned composition, wherein the emulsifier or the surfactant is cetostearyl alcohol, emulsifying wax, steareth-10, or a mixture thereof.
  • the invention relates to any one of the above-mentioned compositions, wherein the emulsifier or the surfactant is present in an amount from about 2% to about 10% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emulsifier or the surfactant is present in an amount from about 3% to about 9% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emulsifier or the surfactant is present in an amount from about 4% to about 8% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the emulsifier or the surfactant is present in an amount from about 3% to about 7% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emulsifier or the surfactant is present in about 4%, about 5%, about 6%, about 7%, or about 8% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the emulsif ⁇ er or the surfactant is present in about 5% by weight of the concentrate.
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate consists essentially of from about 0.5% to about 15% benzoyl peroxide by weight of the concentrate; from about 55% to about 95% water by weight of the concentrate; and from about 0.01 % to about 5 % of a first mixture by weight of the concentrate, wherein the first mixture comprises butylated hydroxytoluene, methylparaben, propylparaben, citric acid, sodium citrate, or disodium EDTA; from about 5% to about 20% of a second mixture by weight of the concentrate, wherein the second mixture comprises dimethicone, C 12 -C 15 alkyl benzoates, glycerol, or propylene glycol; and from about 2% to about 10% of a third mixture by weight of the concentrate, wherein the third mixture comprises cetostearyl alcohol, emulsifying wax, or steareth-10; and the propellant is a hydrofluoroalkan
  • the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in an amount from about 1.0% to about 13% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in an amount from about 2.5% to about 12% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in an amount from about 4.0% to about 7.0% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in about 2.5%, about 3.0%, about 3.5%, about 4.0%, about 5.0%, about 6.0%, about 7.0%, about 8.0%, about 9.0%, about 10.0%, about 11%, or about 12% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein benzoyl peroxide is present in about 5.3% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein water is present in an amount from about 60% to about 90% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein water is present in an amount from about 65% to about 90% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein water is present in an amount from about 72% to about 82% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein water is present in about 65%, about 70%, about 75%, about 80%, about 85%, or about 90% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein water is present in about 77% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the first mixture is present in an amount from about 0.05% to about 3.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the first mixture is present in an amount from about 0.1% to about 2.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the first mixture is present in an amount from about 0.5% to about 1.9% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the first mixture is present in about 0.1%, about 0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%, about 0.8%, about 0.9%, about 1.0%, about 1.5%, or about 2.0% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the first mixture is present in about 1.2% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the second mixture is present in an amount from about 8% to about 17% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the second mixture is present in an amount from about 9% to about 15% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the second mixture is present in an amount from about 9% to about 13% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the second mixture is present in about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, or about 15% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the second mixture is present in about 11% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the third mixture is present in an amount from about 3% to about 9% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the third mixture is present in an amount from about 4% to about 8% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the third mixture is present in an amount from about 3% to about 7% by weight of the concentrate.
  • the invention relates to any one of the above-mentioned compositions, wherein the third mixture is present in about 4%, about 5%, about 6%, about 7%, or about 8% by weight of the concentrate. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the third mixture is present in about 5% by weight of the concentrate.
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate consists essentially of about 5.3% benzoyl peroxide by weight of the concentrate; about 77% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 0.6% sodium citrate by weight of the concentrate; about 0.05% citric acid by weight of the concentrate; about 0.9% dimethicone by weight of the concentrate; about 0.4% C12-C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.2% cetostearyl alcohol by weight of the concentrate; about 2.2% emulsifying wax by weight of the concentrate; and about 0.9% steareth-10 by weight of
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate consists essentially of about 5.3% benzoyl peroxide by weight of the concentrate; about 76.73% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 0.62% sodium citrate by weight of the concentrate; about 0.05% citric acid by weight of the concentrate; about 0.9% dimethicone by weight of the concentrate; about 0.45% Ci 2 -Ci 5 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.25% cetostearyl alcohol by weight of the concentrate; about 2.25% emulsifying wax by weight of the concentrate; and about 0.9% stea
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate consists essentially of about 5.3% benzoyl peroxide by weight of the concentrate; about 76.73% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 0.62% sodium citrate by weight of the concentrate; about 0.05% citric acid by weight of the concentrate; about 0.9% dimethicone by weight of the concentrate; about 0.45% C12-C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.25% cetostearyl alcohol by weight of the concentrate; about 2.25% emulsifying wax by weight of the concentrate; and about 0.9% steareth
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate consists essentially of about 5% benzoyl peroxide by weight of the concentrate; about 77% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 1.0% dimethicone by weight of the concentrate; about 0.5% C 12 -C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.5% cetostearyl alcohol by weight of the concentrate; about 2.5% emulsifying wax by weight of the concentrate; and about 1.0% steareth-10 by weight of the concentrate; and the propellant is 1,1,1,2-tetrafluoroethane or 1,1,
  • the invention relates to a composition consisting essentially of a concentrate and a propellant, wherein the concentrate consists essentially of about 10% benzoyl peroxide by weight of the concentrate; about 72% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 1.0% dimethicone by weight of the concentrate; about 0.5% C 12 -C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.5% cetostearyl alcohol by weight of the concentrate; about 2.5% emulsifying wax by weight of the concentrate; and about 1.0% steareth-10 by weight of the concentrate; and the propellant is 1,1,1,2-tetrafluoroethane or 1,1, 1,
  • the invention relates to a composition consisting of a concentrate and a propellant, wherein the concentrate consists of about 5.3% benzoyl peroxide by weight of the concentrate; about 77% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 0.6% sodium citrate by weight of the concentrate; about 0.05% citric acid by weight of the concentrate; about 0.9% dimethicone by weight of the concentrate; about 0.4% C 12-Ci 5 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.2% cetostearyl alcohol by weight of the concentrate; about 2.2% emulsifying wax by weight of the concentrate; and about 0.9% steareth-10 by weight of the concentrate; and
  • the invention relates to a composition consisting of a concentrate and a propellant, wherein the concentrate consists of about 5.3% benzoyl peroxide by weight of the concentrate; about 76.73% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 0.62% sodium citrate by weight of the concentrate; about 0.05% citric acid by weight of the concentrate; about 0.9% dimethicone by weight of the concentrate; about 0.45% C12-C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.25% cetostearyl alcohol by weight of the concentrate; about 2.25% emulsifying wax by weight of the concentrate; and about 0.9% steareth-10 by weight of
  • the invention relates to a composition consisting of a concentrate and a propellant, wherein the concentrate consists of about 5.3% benzoyl peroxide by weight of the concentrate; about 76.73% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 0.62% sodium citrate by weight of the concentrate; about 0.05% citric acid by weight of the concentrate; about 0.9% dimethicone by weight of the concentrate; about 0.45% C 12 -C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.25% cetostearyl alcohol by weight of the concentrate; about 2.25% emulsifying wax by weight of the concentrate; and about 0.9% steareth-10 by weight
  • the invention relates to a composition consisting of a concentrate and a propellant, wherein the concentrate consists of about 5% benzoyl peroxide by weight of the concentrate; about 77% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 1.0% dimethicone by weight of the concentrate; about 0.5% C 12 -C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.5% cetostearyl alcohol by weight of the concentrate; about 2.5% emulsifying wax by weight of the concentrate; and about 1.0% steareth-10 by weight of the concentrate; and the propellant is 1,1,1,2-tetrafluoroethane or 1,1, 1,2,3, 3,
  • the invention relates to a composition consisting of a concentrate and a propellant, wherein the concentrate consists of about 10% benzoyl peroxide by weight of the concentrate; about 72% water by weight of the concentrate; about 0.05% butylated hydroxytoluene by weight of the concentrate; about 0.3% methylparaben by weight of the concentrate; about 0.1% propylparaben by weight of the concentrate; about 0.1% disodium EDTA by weight of the concentrate; about 1.0% dimethicone by weight of the concentrate; about 0.5% C 12 -C 15 alkyl benzoates by weight of the concentrate; about 7.5% glycerol by weight of the concentrate; about 2.5% propylene glycol by weight of the concentrate; about 2.5% cetostearyl alcohol by weight of the concentrate; about 2.5% emulsifying wax by weight of the concentrate; and about 1.0% steareth-10 by weight of the concentrate; and the propellant is 1,1,1,2-tetrafluoroethane or 1,1, 1,2,3, 3,3
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is colorless.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is in an aerosol container.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is in an aerosol container, thereby forming a headspace of the aerosol container; and the headspace of the aerosol container is substantially free of oxygen. In one embodiment, the invention relates to any one of the above-mentioned compositions, thereby forming a headspace of the aerosol container; and the headspace of the aerosol container consists essentially of argon.
  • the invention relates to any one of the above-mentioned compositions, wherein when the aerosol container is actuated, the composition is expelled as a foam.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is in an aerosol container. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the composition is about 4% to about 50% propellant, by weight of the composition. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the composition is about 5% to about 40% propellant, by weight of the composition. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the composition is about 6% to about 30% propellant, by weight of the composition.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is about 6% to about 18% propellant, by weight of the composition. In one embodiment, the invention relates to any one of the above- mentioned compositions, wherein the composition is about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 20%, about 25%, or about 30% propellant, by weight of the composition. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the composition is about 12% propellant, by weight of the composition.
  • the invention relates to any one of the above-mentioned compositions, wherein about 6%, about 7%, about 8%, about 9%, about 10%, about 11%, about 12%, about 13%, about 14%, about 15%, about 20%, about 25%, or about 30% propellant, by weight of the composition, is required to deliver the concentrate as a stable foam.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is in the form of a foam. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the composition produces a foam.
  • the invention relates to any one of the above-mentioned compositions, wherein the foam is produced by actuation of an aerosol container comprising the composition. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the foam is non-irritating when applied to the skin of a subject.
  • the invention relates to any one of the above-mentioned compositions, wherein the foam is moisturizing over a period of at least 8 hours when applied to the skin of a subject. In one embodiment, the invention relates to any one of the above-mentioned compositions, wherein the composition does not comprise methanol, ethanol, propanols, or butanols.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition does not comprise methane, ethane, propane, butane, pentane, or hexane.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is non-irritating when applied to the skin.
  • the invention relates to any one of the above-mentioned compositions, wherein the composition is moisturizing when applied to the skin.
  • the composition when applied to the skin, the composition is moisturizing over a period of at least 4, at least 6, at least 8, at least 10, or at least 12 hours.
  • the composition when applied to the skin, the composition is moisturizing over a period of up to about 24 hours.
  • the composition when applied to the skin, the composition is moisturizing over a period of up to about 48 hours.
  • the composition is moisturizing over a period of at least 8 hours.
  • the present invention relates to a method of treating a condition of a subject in need thereof, comprising the steps of applying to an affected area of the subject an effective amount of a foam prepared from any one of the above-mentioned compositions.
  • the present invention relates to any one of the above-mentioned methods, further comprising the step of: expelling from an aerosol container any one of the above-mentioned compositions, thereby preparing a foam.
  • the present invention relates to a method of treating a condition of a subject in need thereof, comprising the steps of: applying to an affected area of the subject an effective amount of a foam prepared from any one of the above-mentioned compositions, thereby simultaneously treating and moisturizing the affected area.
  • the present invention relates to a method of treating a condition of a subject in need thereof, comprising the steps of: applying to an affected area of the subject an effective amount of a foam prepared from any one of the above-mentioned compositions, thereby simultaneously treating and hydrating the affected area.
  • the present invention relates to the above-mentioned method, wherein the condition is acne, decubital ulcers, stasis ulcers, burns, varicose ulcers, sycosis vulgaris, or seborrhea. In one embodiment, the present invention relates to any one of the above-mentioned methods, wherein the condition is acne.
  • the present invention relates to any one of the above-mentioned methods, wherein the subject is human.
  • the present invention relates to the above-mentioned method, wherein the affected area of the subject is the face, neck, decolletage, or back. In one embodiment, the present invention relates to the above-mentioned method, wherein the affected area of the subject is the face. In one embodiment, the present invention relates to the above-mentioned method, wherein the affected area of the subject is the decolletage or back. In one embodiment, the present invention relates to any one of the above-mentioned methods, wherein the composition is applied once daily.
  • the present invention relates to any one of the above-mentioned methods, wherein the composition is applied twice daily.
  • the invention relates to a method, comprising the steps of: heating water in a first container; adding glycerol, propylene glycol, methylparaben, propyl paraben, and disodium EDTA to the first container, thereby making an aqueous mixture; heating the aqueous mixture until the aqueous mixture reaches about 70 0 C to about 75 0 C, thereby forming an aqueous solution; mixing cetostearyl alcohol, emulsifying wax, steareth-10, dimethicone, C 12 -C 15 alkyl benzoates, and butylated hydroxytoluene in a second container, thereby forming a nonaqueous mixture; heating the nonaqueous mixture until the nonaqueous mixture reaches about 70 0 C to about 75 0 C, thereby forming a nonaqueous solution; adding the aqueous solution to the nonaqueous solution, thereby forming a first mixture; homogenizing and cooling the first
  • the invention relates to a method, comprising the steps of: heating water in a first container; adding glycerol, propylene glycol, methylparaben, propyl paraben, citric acid, sodium citrate, and disodium EDTA to the first container, thereby making an aqueous mixture; heating the aqueous mixture until the aqueous mixture reaches about 70 0 C to about 75 0 C, thereby forming an aqueous solution; mixing cetostearyl alcohol, emulsifying wax, steareth-10, dimethicone, C 12 -C 15 alkyl benzoates, and butylated hydroxytoluene in a second container, thereby forming a nonaqueous mixture; heating the nonaqueous mixture until the nonaqueous mixture reaches about 70 0 C to about 75 0 C, thereby forming a nonaqueous solution; adding the aqueous solution to the nonaqueous solution, thereby forming a first mixture
  • the present invention relates to the above-mentioned method, further comprising the step of placing the fourth mixture in an aerosol container.
  • the present invention relates to the above-mentioned method, further comprising the step of: purging the aerosol container with an inert gas, wherein the inert gas is argon or nitrogen.
  • the present invention relates to the above-mentioned method, further comprising the step of: adding a propellant to the aerosol container, wherein the propellant is a hydrofluoroalkane.
  • A-H Multiple formulations (A-H) of benzoyl peroxide were made in order to study the effect of antioxidants or an argon purge on the stability of the formulations (Table 1).
  • the antioxidant blend contained the following composition: butylated hydro xytoluene (BHT) (21.5 g, 86%), propyl gallate (2.5 g, 10%), and t-butylhydroquinone (TBHQ) (1.0 g, 4%).
  • BHT butylated hydro xytoluene
  • TBHQ t-butylhydroquinone
  • the samples were put into glass jars with aerosol valves and stored under various temperatures (4 0 C, 25 0 C, 30 0 C, and 40 0 C).
  • a 5% BPO foam concentrate was formulated.
  • the quantities used are depicted in Table 3.
  • a similar procedure may be used to formulate any other BPO formulation.
  • Table 3. 5% Benzoyl Peroxide Foam Concentrate Formulation.
  • the concentrate was made as follows: purified water (705.5 g) was weighed in a beaker. The beaker was then heated on a hotplate. Glycerol (75.0 g), propylene glycol (2.50 g), methylparaben (3.0 g), propylparaben (1.0 g), and disodium ethylenediaminetetraacetic acid (disodium EDTA) (1.0 g) were added to the warm beaker. The mixture was heated to 70-75 0 C, until all solids were dissolved, thus forming the aqueous phase.
  • cetostearyl alcohol (25.0 g), emulsifying wax (25.0 g), steareth-10 (10.0 g), dimethicone (10.0 g), C 12 -C 15 alkyl benzoates (5.0 g), and butylated hydroxytoluene (BHT) (0.5 g) were weighed in a beaker.
  • the beaker was heated to 70-75 0 C to dissolve, melt, and mix the contents uniformly, thus forming the oil phase.
  • the aqueous phase was added to the oil phase and the mixture homogenized for 5 minutes with a Silverson Homogenizer set at speed 6.5.
  • the emulsion was then cooled with the outside cold water jacket to 40-45 0 C while mixing at dial 5.5.
  • the Silverson homogenizer was removed and a lightning mixer was used, with continued cooling. Once the mixture reached 30 0 C, cooling was halted and thoroughly-mixed benzoyl peroxide (50.0 g) (in the form of BPO 42 USP gel, 114 g) was added slowly with rapid stirring. The mixture was mixed until dispersed. If necessary, the Silverson homogenizer may be used to disperse the BPO for 5-10 minutes at speed 5.5.
  • Formulations W-Z demonstrated a similar benzoyl peroxide stability profile as example J in Table 6. This demonstrates that the addition of pharmaceutically acceptable buffers does not impact benzoyl peroxide stability in the aerosol foam formulations. It was discovered that the addition of buffer further reduced the color formation of the formulations (on stability). It was also discovered that the addition of buffer helped to stabilize the viscosity of the formulations, resulting in the improved dispensing of the formulation from the aerosol container closure system. The previous un-buffered example J in Table 6 showed an increase in viscosity on stability and demonstrated difficulty in shaking and dispensing (clogging) from the aerosol container closure system. Example 6
  • Subjects were treated with a blank, an aerosol foam vehicle, a 3.3% BPO aerosol foam, or a 5.3% BPO aerosol foam for five days.
  • a Konica Minolta CR-400 Chroma Meter was used each day to measure the a*-value of the treated area of each subject.
  • the a*-value used was a measure of the red-green scale in CIE L*a*b* (CIELAB) Color Space.
  • Negative a* -values indicate green, while positive a* -values indicate red or magenta.
  • the data demonstrate no significant difference in the a*-value between all treatments.
  • the data also demonstrate no statistically-significant difference in a* -value over time for each treatment. Redness is an indication of skin irritation or erythema. See Figure 3.
  • Example 7 Comparison of Various BPO Topical Formulations on Stratum Corneum Moisture Values
  • Subjects (n 10) were treated with 5.3% BPO aerosol foam, 5% BPO/ 1% Clindamycin gel, or 5% BPO gel, and the level of hydration of the stratum corneum in the treated area was measured over time.
  • the data demonstrate the superior hydrating or moisturizing properties of 5.3% BPO aerosol foam versus commercially available treatments.
  • the aerosol foam produces a statistically significant difference (p ⁇ 0.05) in hydration at the 95% confidence interval. See Figure 4.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Dermatology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention porte sur des compositions de peroxyde de benzoyle utiles dans le traitement de l'acné et autres états cutanés, présentant une stabilité accrue, même dans des conditions accélérées. Les compositions présentent également une formation de couleur réduite, une irritation réduite et des propriétés d'hydratation améliorées. Elles peuvent être formulées selon une mousse aérosol topique avec des propulseurs inertes, non inflammables, tels que les hydrofluoroalcanes et peuvent être utilisées en tant que produits cosmétiques ou pharmaceutiques. De plus, l'invention porte sur des procédés de fabrication de ces compositions.
EP09840157.3A 2009-02-12 2009-08-24 Compositions moussantes de peroxyde de benzoyle pour administration topique Withdrawn EP2395994A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15202209P 2009-02-12 2009-02-12
PCT/US2009/054752 WO2010093382A1 (fr) 2009-02-12 2009-08-24 Compositions moussantes de peroxyde de benzoyle pour administration topique

Publications (2)

Publication Number Publication Date
EP2395994A1 true EP2395994A1 (fr) 2011-12-21
EP2395994A4 EP2395994A4 (fr) 2013-05-22

Family

ID=42540579

Family Applications (1)

Application Number Title Priority Date Filing Date
EP09840157.3A Withdrawn EP2395994A4 (fr) 2009-02-12 2009-08-24 Compositions moussantes de peroxyde de benzoyle pour administration topique

Country Status (5)

Country Link
US (2) US20100202978A1 (fr)
EP (1) EP2395994A4 (fr)
CA (1) CA2752070C (fr)
MX (1) MX354480B (fr)
WO (1) WO2010093382A1 (fr)

Families Citing this family (25)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL152486A0 (en) 2002-10-25 2003-05-29 Meir Eini Alcohol-free cosmetic and pharmaceutical foam carrier
US10117812B2 (en) 2002-10-25 2018-11-06 Foamix Pharmaceuticals Ltd. Foamable composition combining a polar solvent and a hydrophobic carrier
US9265725B2 (en) 2002-10-25 2016-02-23 Foamix Pharmaceuticals Ltd. Dicarboxylic acid foamable vehicle and pharmaceutical compositions thereof
US9668972B2 (en) 2002-10-25 2017-06-06 Foamix Pharmaceuticals Ltd. Nonsteroidal immunomodulating kit and composition and uses thereof
US7704518B2 (en) 2003-08-04 2010-04-27 Foamix, Ltd. Foamable vehicle and pharmaceutical compositions thereof
US7700076B2 (en) 2002-10-25 2010-04-20 Foamix, Ltd. Penetrating pharmaceutical foam
ES2532906T5 (es) 2002-10-25 2022-03-23 Foamix Pharmaceuticals Ltd Espuma cosmética y farmacéutica
US20080138296A1 (en) 2002-10-25 2008-06-12 Foamix Ltd. Foam prepared from nanoemulsions and uses
EP2100601B1 (fr) * 2005-10-24 2012-06-27 Precision Dermatology, Inc. Composition de mousse pharmaceutique topique
US20080260655A1 (en) 2006-11-14 2008-10-23 Dov Tamarkin Substantially non-aqueous foamable petrolatum based pharmaceutical and cosmetic compositions and their uses
US8636982B2 (en) 2007-08-07 2014-01-28 Foamix Ltd. Wax foamable vehicle and pharmaceutical compositions thereof
WO2009069006A2 (fr) 2007-11-30 2009-06-04 Foamix Ltd. Peroxyde de benzoyle contenant de la mousse
WO2009072007A2 (fr) 2007-12-07 2009-06-11 Foamix Ltd. Porteurs, formulations, procédés pour formuler des agents actifs instables pour application externe et utilisations associées
CA2760186C (fr) 2009-04-28 2019-10-29 Foamix Ltd. Vehicule moussant et compositions pharmaceutiques comportant des solvants polaires aprotiques et leurs utilisations
CA2769625C (fr) 2009-07-29 2017-04-11 Foamix Ltd. Compositions hydro-alcooliques moussantes non tensioactives, mousses legeres, et leurs utilisations
CA2769677A1 (fr) 2009-07-29 2011-02-03 Foamix Ltd. Compositions hydro-alcooliques moussantes a base d'agents non tensioactifs non polymeres, mousses legeres, et leurs utilisations
US9849142B2 (en) 2009-10-02 2017-12-26 Foamix Pharmaceuticals Ltd. Methods for accelerated return of skin integrity and for the treatment of impetigo
MX359879B (es) 2009-10-02 2018-10-12 Foamix Pharmaceuticals Ltd Composiciones tópicas de tetraciclina.
CA2794503C (fr) * 2010-03-26 2017-11-07 Precision Dermatology, Inc. Mousses aerosols comprenant du phosphate de clindamycine
FR2969493B1 (fr) * 2010-12-23 2013-07-05 Galderma Res & Dev Mousses dermatologiques obtenues a partir d'un gel ou d'une suspension contenant du bpo
US8481480B1 (en) 2012-04-30 2013-07-09 Uyen T. Lam Anti-adherent formulation including a quaternary ammonium compound and a fatty alcohol
CN108601733B (zh) * 2015-12-15 2021-11-09 治疗学有限公司 卤倍他索泡沫组合物及其使用方法
MX2017011630A (es) 2016-09-08 2018-09-25 Foamix Pharmaceuticals Ltd Composiciones y metodos para tratar rosacea y acne.
WO2021171321A1 (fr) 2020-02-28 2021-09-02 Taramar Seeds Ehf. Formulations cosmétiques à couche d'argon et réservoir d'argon interne et procédés de fabrication de telles formulations
WO2023177625A1 (fr) * 2022-03-14 2023-09-21 Blue Hill Technologies Llc Formulations de peroxyde de benzoyle à longue conservation et leurs procédés de production

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040151671A1 (en) * 2003-01-24 2004-08-05 Connetics Australia Pty Ltd. Pharmaceutical foam
WO2005032522A1 (fr) * 2003-10-03 2005-04-14 Collegium Pharmaceutical, Inc. Mousses aerosol topiques
US20070237724A1 (en) * 2006-03-31 2007-10-11 Abram Albert Z Foamable suspension gel
US20080069779A1 (en) * 2003-08-04 2008-03-20 Foamix Ltd. Foamable vehicle and vitamin and flavonoid pharmaceutical compositions thereof

Family Cites Families (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0212047D0 (en) * 2002-05-24 2002-07-03 Btg Int Ltd Generation of therapeutic microfoam
US7700076B2 (en) * 2002-10-25 2010-04-20 Foamix, Ltd. Penetrating pharmaceutical foam
US20080031907A1 (en) * 2002-10-25 2008-02-07 Foamix Ltd. Cosmetic and pharmaceutical foam
US20060193789A1 (en) 2002-10-25 2006-08-31 Foamix Ltd. Film forming foamable composition
WO2005115336A2 (fr) 2004-05-15 2005-12-08 Collegium Pharmaceutical, Inc. Formulations pulverisables destinees au traitement d'etats dermiques inflammatoires aigus
US7153888B2 (en) * 2004-12-21 2006-12-26 Alpharx Inc. Stabilization of benzoyl peroxide in solution
GB0518769D0 (en) * 2005-09-14 2005-10-19 Medpharm Ltd Topical formulations
EP2100601B1 (fr) * 2005-10-24 2012-06-27 Precision Dermatology, Inc. Composition de mousse pharmaceutique topique
JP2009519957A (ja) 2005-12-14 2009-05-21 ザーズ， インコーポレイテッド 薬物の皮膚送達のためのスプレイ−オン処方物および方法
WO2009069006A2 (fr) * 2007-11-30 2009-06-04 Foamix Ltd. Peroxyde de benzoyle contenant de la mousse
CA2794503C (fr) * 2010-03-26 2017-11-07 Precision Dermatology, Inc. Mousses aerosols comprenant du phosphate de clindamycine
US8784780B2 (en) * 2010-06-11 2014-07-22 Precision Dermatology, Inc. High oil-content emollient aerosol foam compositions

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040151671A1 (en) * 2003-01-24 2004-08-05 Connetics Australia Pty Ltd. Pharmaceutical foam
US20080069779A1 (en) * 2003-08-04 2008-03-20 Foamix Ltd. Foamable vehicle and vitamin and flavonoid pharmaceutical compositions thereof
WO2005032522A1 (fr) * 2003-10-03 2005-04-14 Collegium Pharmaceutical, Inc. Mousses aerosol topiques
US20070237724A1 (en) * 2006-03-31 2007-10-11 Abram Albert Z Foamable suspension gel

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
BOWE W P ET AL: "Effective Over-the-Counter Acne Treatments", SEMINARS IN CUTANEOUS MEDICINE AND SURGERY, W.B. SAUNDERS, PHILADELPHIA, US, vol. 27, no. 3, 1 September 2008 (2008-09-01), pages 170-176, XP025347198, ISSN: 1085-5629, DOI: 10.1016/J.SDER.2008.07.004 [retrieved on 2008-09-09] *
See also references of WO2010093382A1 *
YANJUN ZHAO ET AL: "The topical delivery of benzoyl peroxide using elegant dynamic hydrofluoroalkane foams", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 99, no. 3, 1 March 2010 (2010-03-01), pages 1384-1398, XP055059166, ISSN: 0022-3549, DOI: 10.1002/jps.21933 *

Also Published As

Publication number Publication date
US20140140937A1 (en) 2014-05-22
WO2010093382A1 (fr) 2010-08-19
US20100202978A1 (en) 2010-08-12
CA2752070A1 (fr) 2010-08-19
CA2752070C (fr) 2017-11-28
MX2011008273A (es) 2011-10-21
EP2395994A4 (fr) 2013-05-22
MX354480B (es) 2018-03-07

Similar Documents

Publication Publication Date Title
CA2752070C (fr) Compositions moussantes de peroxyde de benzoyle pour administration topique
US9370487B2 (en) High oil-content emollient aerosol foam compositions
US8592380B2 (en) Aerosol foams comprising clindamycin phosphate
US9018236B2 (en) Cyclodextrin-based microemulsions, and dermatological uses thereof
US20130115173A1 (en) Stable Dermatological Aerosol Foams Utilizing Reactive Propellants
US20110052506A1 (en) Stable Aerosol Topical Foams Comprising a Hypochlorite Salt
US20120148516A1 (en) Tandem Hypochlorite-Barrier Repair Therapy for the Treatment of Eczema
CA2714015C (fr) Compositions pharmaceutiques et cosmetiques moussantes a base de petrolatum, sensiblement non aqueuses et leurs utilisations
US7704518B2 (en) Foamable vehicle and pharmaceutical compositions thereof
AU2006313443A1 (en) Foamable vehicle and pharmaceutical compositions thereof
AU2014223226A1 (en) Topical formulations of corticosteroids with enhanced bioavailability
WO2010093523A2 (fr) Compositions de microémulsions moussantes destinées à une administration topique

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20110908

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO SE SI SK SM TR

DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20130422

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 9/12 20060101ALI20130416BHEP

Ipc: A61P 17/10 20060101ALI20130416BHEP

Ipc: A61K 47/06 20060101ALI20130416BHEP

Ipc: A61K 31/327 20060101AFI20130416BHEP

17Q First examination report despatched

Effective date: 20150416

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

RIC1 Information provided on ipc code assigned before grant

Ipc: A61K 31/327 20060101ALI20180205BHEP

Ipc: A61K 9/00 20060101ALI20180205BHEP

Ipc: A61K 47/06 20060101ALI20180205BHEP

Ipc: A61K 9/12 20060101AFI20180205BHEP

Ipc: A61P 17/10 20060101ALI20180205BHEP

INTG Intention to grant announced

Effective date: 20180315

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20180726